Dose of Spinal Manipulation for Chronic Low Back Pain

This study has been completed.

Sponsor:

Collaborator:

National Center for Complementary and Alternative Medicine (NCCAM)

Information provided by (Responsible Party):

Mitchell Haas, University of Western States

ClinicalTrials.gov Identifier:

NCT00376350

First received: September 12, 2006

Last updated: February 2, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2006

Last Updated Date

February 2, 2012

Start Date ^ICMJE

March 2007

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Modified Von Korff Pain Scale for low back pain [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Modified Von Korff Disability Scale [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Modified Von Korff Pain Scale for low back pain
Modified Von Korff Disability Scale

Change History

Complete list of historical versions of study NCT00376350 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pain days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Disability days [ Time Frame: baseline 1&2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Low back pain unpleasantness [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Fear avoidance beliefs [ Time Frame: baseline 2, 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
General health status/QoL [ Time Frame: baseline 2; 12, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Patient satisfaction [ Time Frame: 12 wk ] [ Designated as safety issue: No ]
Healthcare utilization [ Time Frame: baseline 2; 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]
Objective measures [ Time Frame: Baseline 2, 6 wk ] [ Designated as safety issue: No ]
Bias monitoring [ Time Frame: baseline 1&2; 6, 12, 18, 24, 39, 52 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Pain days
Disability days
Low back pain unpleasantness
Fear avoidance beliefs
General health status/QoL
Patient satisfaction
Healthcare utilization
Objective measures
Bias monitoring

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Dose of Spinal Manipulation for Chronic Low Back Pain

Official Title ^ICMJE

Dose-Response/Efficacy of Manipulation for Chronic LBP

Brief Summary

This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

Procedure: Spinal Manipulation
5 minutes high velocity, low amplitude lumbar thrust
Procedure: Light Massage
light pressure massage of the low back.
Procedure: Pulsed Ultrasound
5 minutes pulsed ultrasound

Study Arm (s)

Experimental: High dose manipulation
High dose spinal manipulation + ultrasound
Interventions:
- Procedure: Spinal Manipulation
- Procedure: Pulsed Ultrasound
Experimental: Moderate dose manipulation
Moderate dose manipulation + low dose massage + ultrasound
Interventions:
- Procedure: Spinal Manipulation
- Procedure: Light Massage
- Procedure: Pulsed Ultrasound
Experimental: Low dose manipulation
low dose spinal manipulation + moderate dose massage + ultrasound
Interventions:
- Procedure: Spinal Manipulation
- Procedure: Light Massage
- Procedure: Pulsed Ultrasound
High dose masssage
high dose massage + ultrasound
Interventions:
- Procedure: Light Massage
- Procedure: Pulsed Ultrasound

Publications *

Haas M, Groupp E, Kraemer DF. Dose-response for chiropractic care of chronic low back pain. Spine J. 2004 Sep-Oct;4(5):574-83.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

July 2011

Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Current episode of low back pain
mechanical origin
Threshold low back pain level

Exclusion Criteria:

Contraindications to spinal manipulation or massage
Complicating conditions that could confound clinical outcome
Prophylactic use of prescription medication
Health-related litigation, claims, or disability compensation

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00376350

Other Study ID Numbers ^ICMJE

U01 AT001908, U01AT001908

Has Data Monitoring Committee

Yes

Responsible Party

Mitchell Haas, University of Western States

Study Sponsor ^ICMJE

University of Western States

Collaborators ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators ^ICMJE

Principal Investigator:

Mitchell Haas, DC, MA

University of Western States

Information Provided By

University of Western States

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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